CryoSpray Ablation(TM)to Determine Safety and Feasibility in Radiation Induced Proctitis

Phase 4

Withdrawn

• Conditions: Radiation Proctitis; Radiation Induced Proctitis
• Interventions: Device: Cryo Spray Ablation Group 1; Device: Cryo Spray Ablation Group 2

• Registration Number: NCT00756197
• Lead Sponsor: CSA Medical, Inc.

Brief Summary

The purpose of this study is to evaluate the safety, feasibility, tissue response, and subject side effects of liquid nitrogen sprayed through a catheter (CryoSpray AblationTM, "CSA" or "cryospray therapy") via endoscope in subjects with radiation induced proctitis.

Detailed Description

The proposed study is a single center, ten patient pilot study to evaluate the safety and feasibility of sprayed liquid nitrogen through a catheter via endoscope in subjects with radiation proctitis. There will be two groups. Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy. Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.

Study Timeline

• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-18
• Study First Posted: 2008-09-22
• Study Start: 2008-10
• Primary Completion: 2009-03
• Study Completion: 2009-09
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-06
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age 18 years of age
• Have radiation induced proctitis

Exclusion Criteria

• Pregnant or nursing
• Planning to become pregnant during the course of the study
• Planning to sire a child while enrolled in the study
• Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.

Subject has prior or concurrent ablation therapy including, but not limited to, photodynamic therapy, multipolar electro coagulation, argon plasma coagulation, laser treatment, radio frequency, etc

• Refusal or inability to give consent.
• Concurrent chemotherapy.
• Medical contraindication or potential problem that would preclude study participation
• Concurrent participation in other experimental studies
• Uncontrolled coagulopathy or bleeding diathesis
• Portal hypertension due to cirrhosis manifest by esophageal, gastric or rectal varices

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryo Spray Ablation Group 1	Cryo Spray Ablation Group 1	4 cycles of 10 seconds each
Cryo Spray Ablation Group 2	Cryo Spray Ablation Group 2	2 cycles of 20 seconds each

Primary Outcome Measures

Name	Time	Method
The primary endpoints for this study are patient safety, treatment efficacy, and feasibility of cryospray therapy in subjects with radiation proctitis.	End of Study

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints for the study are the cataloging of side effects, and tissue response as determined by endoscopic visual evaluation.	End of Study